Shorter Benznidazole Regimens Compared to the Standard Regimen for Chagas Disease
Recruiting
Phase 3
Interventional Study
Chagas Disease
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 60
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 300 (estimated)
- Sponsor
- Laboratorio Elea Phoenix S.A. · Industry
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About This Trial
Chagas disease, a parasitic infection caused by Trypanosoma cruzi, is endemic in much of Latin America and affects people throughout the world. Currently treatment with the only two drugs effective against the infection, benznidazole and nifurtimox, has significant limitations including frequent adverse effects in adult patients. However, timely treatment is key to achieving global objectives of c…
Trial Locations
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Eligibility Criteria
Inclusion criteria (Subjects must meet ALL the inclusion requirements listed below to enter the study):
* Signed informed consent form;
* Between ≥18 and ≤60 years of age;
* Weight ≥ 50 kg to ≤ 95 kg;
* Confirmation of the diagnosis of T. cruzi infection by conventional serology (a minimum of two t…
Contacts